The second IDE approval comes a few months after the Geneva, Switzerland-based company won IDE approval for the device in the treatment of below-the-knee indication.
Enrollment in the Selution SLR IDE SFA study will begin later this year and will be conducted at over 20 centers in the U.S. and an additional 20 centers globally. MedAlliance plans to enroll 300 patients in the study to demonstrate superiority over balloon angioplasty for treating peripheral artery disease (PAD).
“This is a significant milestone for MedAlliance: we are the first non-paclitaxel drug-coated balloon to receive IDE approval, and now the first to have two applications approved. This is the culmination of a multi-year R&D program to provide the comprehensive non-clinical data required to satisfy the very high standards expected by the US FDA,” CEO Jeffrey Jump said in a news release. “We are very pleased with the rapid level of sales growth we are experiencing in Europe, Asia and South America and very much look forward to entering the US market.”
The study will be conducted by principal investigator Dr. George Adams, director of cardiovascular and peripheral vascular research at Rex Hospital in Raleigh, N.C.
“We are very excited that U.S. patients suffering from PAD will have the opportunity to receive this novel sirolimus drug-coated balloon technology. This is yet another advancement in the field of treating vascular disease and we are confident that this study will enroll quickly,” said Adams.
Selution SLR was granted CE mark approval to treat peripheral artery disease in February 2020 and to treat coronary artery disease in May 2020. It has won four breakthrough device designations in the U.S. for the treatment of atherosclerotic lesions in native coronary arteries; coronary in-stent restenosis; peripheral below-the-knee and AV-fistula indications.
The company enrolled the first patient in its below-the-knee IDE clinical trial in June to demonstrate superior efficacy and equivalent safety for Selution SLR compared to uncoated balloon angioplasty to treat below-the-knee arteries in chronic limb-threatening ischemia patients.
MedAlliance’s Selution SLR has unique MicroReservoirs that are made from a biodegradable polymer that is intermixed with the anti-restenotic drug sirolimus. The MicroReservoirs provide controlled and sustained release of the drug.